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Cerebellar Ataxia clinical trials

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NCT ID: NCT01776164 Completed - Friedreich Ataxia Clinical Trials

Early and Longitudinal Assessment of Neurodegeneration in the Brain and Spinal Cord in Friedreich's Ataxia

Start date: January 2013
Phase:
Study type: Observational

Friedreich's ataxia is characterized by progressive alterations in the function of the cerebellum accompanied by an atrophy of the spinal cord. Although the genetic defect responsible for the disease has been identified more than 15 years ago, objective markers of the pathologic process (i.e., biomarkers) that would allow measuring the effects of potential therapies are still lacking. Moreover, it is still unclear how the malfunction of the cerebellum affects the rest of the brain, and understanding the connectivity and neurochemistry of the central nervous system might yield new insights in the understanding of the disease, in addition to providing potential markers. To address these needs, the investigators aim at utilizing the capabilities of Magnetic Resonance Imaging (MRI) and Spectroscopy (MRS). Using techniques called Diffusion Imaging, resting-state functional MRI, and Proton Spectroscopy (1H MRS), the investigators propose to determine the differences in the connectivity and neurochemistry of the spinal cord and the brain between patients affected by Friedreich's ataxia and healthy controls. The investigators plan on imaging both patients and control subjects using a 3T magnet, a system that although not yet available in all medical facilities, is becoming standard in most hospitals and clinics. The first aim is to scan patients already scanned last year (12-month follow-up). The second aim is to scan patients at an early stage of the disease.

NCT ID: NCT01728064 Completed - Friedreich's Ataxia Clinical Trials

Safety and Efficacy of EPI-743 in Patients With Friedreich's Ataxia

Start date: December 31, 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to examine the effects of EPI-743 on visual function and neurologic function in patients with Friedreich's ataxia.

NCT ID: NCT01649687 Completed - Cerebellar Ataxia Clinical Trials

Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells

Start date: May 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The study is to investigate the efficacy and safety of allogenous transplantation of adipose-derived mesenchyma stem cells in patients with cerebellar ataxia.

NCT ID: NCT01493973 Completed - Friedreich Ataxia Clinical Trials

Efficacy Study of Epoetin Alfa in Friedreich Ataxia

FRIEMAX
Start date: January 2013
Phase: Phase 2
Study type: Interventional

Friedreich's ataxia (FRDA) is a rare genetic disorder characterised by severe neurological disability and cardiomyopathy. Friedreich's ataxia is the consequence of frataxin deficiency. Although several drugs have been proposed, there is no available treatment. Four trials recently demonstrated that erythropoietin can increase the intracellular levels of frataxin. The present project is aimed at testing a long term therapeutic approach using erythropoietin, which is an already available and commercialised drug. The study will test the effect of erythropoietin on exercise capacity, which is reduced in patients with FRDA. Additional objectives of the study will be the drug's safety and tolerability, and its effect on frataxin, blood vessel reactivity, heart functional indexes, and disease progression.

NCT ID: NCT01488461 Completed - Clinical trials for Early-onset Cerebellar Ataxias

Phenotypic and Genotypic Studies in Congenital and Early Onset Ataxias

ATAXIC
Start date: January 2012
Phase: N/A
Study type: Observational

Congenital ataxias (CA) are rare, non progressive diseases, characterized by psychomotor retardation, hypotonia followed by ataxia. The presence of the "molar tooth" on MRI allowed to define Joubert syndrome, a peculiar form of CA. Apart from this group, CA are mostly associated with cerebellar atrophy or hypoplasia without molar tooth on MRI. CA are a clinically as well as genetically heterogeneous group of diseases. Early-onset ataxias are progressive but may be difficult to distinguish from CA in the first years of the disease. To date, few genes responsible for CA have been identified: ABC7 (X-linked CA associated with sideroblastic anemia), SLC9A6 (X-linked CA associated with severe mental retardation, autism and epilepsy), GPR56 (CA associated with polymicrogyria), ATCAY (pure CA in Cayman isolate); the involvement of the ATCAY and ABC7 genes has never been assessed in a large cohort of CA patients. Primary objective: To assess the frequency of mutations of the ATCAY and ABC7 genes in patients affected with non Joubert congenital or early-onset ataxia. Secondary objective: To identify new loci and/or genes responsible for CA To further describe the clinical phenotype of the CA and to assess the frequency of the various clinical types (pure CA/CA associated with spasticity/ syndromic CA, congenital/early-onset CA, sporadic/familial CA). To describe the clinical phenotype of CA related to mutations in one of analysed genes.

NCT ID: NCT01470729 Completed - Clinical trials for Spinocerebellar Ataxia Type 1

Biomarkers in Autosomal Dominant Cerebellar Ataxia

BIOSCA
Start date: November 2011
Phase:
Study type: Observational

Autosomal dominant cerebellar ataxias (ADCA) are a group of neurodegenerative disorders that are clinically and genetically various. BIOSCA study aims to identify markers of the metabolism (energy production inside the cells) in the blood and the brain of ADCA 1,2,3 and 7 patients and control subjects, in the perspective of future therapeutic trials.

NCT ID: NCT01350440 Completed - Clinical trials for Spinocerebellar Ataxia

Safety and Efficacy of Intravenous Immune Globulin in Treating Spinocerebellar Ataxia

Start date: August 2011
Phase: Phase 2
Study type: Interventional

This is a preliminary study to determine the safety and efficacy of intravenous immune globulin in treating Spinocerebellar Ataxia. The investigators aim to assess changes in clinical measures of disease severity before and after treatment.

NCT ID: NCT01339884 Completed - Friedreich Ataxia Clinical Trials

A Study of Resveratrol as Treatment for Friedreich Ataxia

Start date: April 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the effect of two doses of resveratrol taken for a 12 week period, on frataxin levels in individuals with Friedreich ataxia. This study will also measure the effect of resveratrol on markers of oxidative stress, clinical measures of ataxia, and cardiac parameters.

NCT ID: NCT01307176 Completed - Cerebellar Ataxia Clinical Trials

Exercise Training Program for Cerebellar Ataxia

Start date: February 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a person's ability to adapt (i.e. short term motor learning) predicts their ability to benefit from physical therapy exercises.

NCT ID: NCT01303406 Completed - Friedreich's Ataxia Clinical Trials

Patient Reported Outcomes in Friedreich's Ataxia Patients After Withdrawal From Treatment With Idebenone (PROTI)

PROTI
Start date: April 2011
Phase: Phase 3
Study type: Interventional

This is a Phase IIIb Double-Blind, Randomised, Placebo-Controlled Study. The aim is to further investigate the effects of idebenone in patients with Friedreich's ataxia. The objective of the PROTI study is to establish whether patients can correctly determine which treatment assignment (placebo or idebenone) they received during the randomised phase of the trial, and identify any potential changes on symptoms or activities.